Use, Effects and Side-effects of Second-generation Antipsychotics in a Naturalistic Setting (BPP)

This study has been completed.
Sponsor:
Information provided by:
University of Bergen
ClinicalTrials.gov Identifier:
NCT00932529
First received: July 2, 2009
Last updated: May 24, 2010
Last verified: December 2003
  Purpose

Despite different pharmacological properties, the scientific evidence is inconclusive regarding which of the first-line second generation antipsychotics (SGAs) should be preferred for the individual patient suffering from psychosis. The limitations of the evidence base may be related to the highly selected samples, short duration, and rigid experimental designs of most randomized clinical trials of efficacy. Moreover a high proportion of the clinical trials are drug company sponsored which could introduce funding bias. The purpose of this non-commercially funded study is to investigate whether effectiveness differences exist among the first-line SGAs olanzapine, quetiapine, risperidone, and ziprasidone when the drugs are used in a representative clinical setting. Eligible patients are those admitted to hospital for acute psychosis and candidates for oral antipsychotic treatment. The investigators hypothesise that in the naturalistic setting of every-day clinical practice and in a diverse sample representative of most patients admitted for symptoms of acute psychosis, differential effectiveness among the SGAs could be disclosed when the patients are followed for up to 2 years. This could deliver valuable information regarding which SGA should be the starting antipsychotic drug in order to facilitate the most beneficial outcome.


Condition Intervention Phase
Psychotic Disorders
Drug: Olanzapine
Drug: Quetiapine
Drug: Risperidone
Drug: Ziprasidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Use, Effects and Side-effects of Second-generation Antipsychotics in a Naturalistic Setting.

Resource links provided by NLM:


Further study details as provided by University of Bergen:

Primary Outcome Measures:
  • Reduction of PANSS total score [ Time Frame: Admission, discharge/ 6 weeks if not discharged, 3, 6, 12, 24 months after admittance. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability [ Time Frame: Discharge/ after 6 weeks if not discharged, 3, 6, 12, 24 months after discharge ] [ Designated as safety issue: Yes ]
  • Time until initial drug discontinuation [ Time Frame: Up to 24 months follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 226
Study Start Date: February 2003
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Olanzapine Drug: Olanzapine
Olanzapine tablets 2.5mg - 20 mg per day once daily, or at the treating clinicians discretion
Other Name: Zyprexa
Drug: Quetiapine
Tablets, 25 mg-800 mg given twice daily, or at the treating clinicians discretion.
Other Name: Seroquel
Drug: Ziprasidone
Tablets, 20mg - 160 mg twice daily, or at the treating clinicians discretion
Other Name: Zeldox, Geodon
Active Comparator: Quetiapine Drug: Olanzapine
Olanzapine tablets 2.5mg - 20 mg per day once daily, or at the treating clinicians discretion
Other Name: Zyprexa
Drug: Risperidone
Tablets, 1mg-6mg per day, once or twice daily, or at the treating clinicians discretion.
Other Name: Risperdal
Drug: Ziprasidone
Tablets, 20mg - 160 mg twice daily, or at the treating clinicians discretion
Other Name: Zeldox, Geodon
Active Comparator: Risperidone Drug: Olanzapine
Olanzapine tablets 2.5mg - 20 mg per day once daily, or at the treating clinicians discretion
Other Name: Zyprexa
Drug: Ziprasidone
Tablets, 20mg - 160 mg twice daily, or at the treating clinicians discretion
Other Name: Zeldox, Geodon
Active Comparator: Ziprasidone Drug: Olanzapine
Olanzapine tablets 2.5mg - 20 mg per day once daily, or at the treating clinicians discretion
Other Name: Zyprexa
Drug: Ziprasidone
Tablets, 20mg - 160 mg twice daily, or at the treating clinicians discretion
Other Name: Zeldox, Geodon

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Psychosis
  • Must be able to use oral antipsychotic drugs

Exclusion Criteria:

  • Mania
  • Unable to cooperate with the assessments
  • Unable to understand Norwegian language
  • Candidates for electroconvulsive therapy
  • Use of Clozapine at admittance
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932529

Locations
Norway
Haukeland University Hospital, Division of Psychiatry
Bergen, Sandviken, Norway, N-5035
Sponsors and Collaborators
University of Bergen
  More Information

No publications provided by University of Bergen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hugo A. Jørgensen, University of Bergen
ClinicalTrials.gov Identifier: NCT00932529     History of Changes
Other Study ID Numbers: NSD-ID10591
Study First Received: July 2, 2009
Last Updated: May 24, 2010
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by University of Bergen:
Antipsychotic drugs
Treatment effectiveness
Randomized controlled trial

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Risperidone
Quetiapine
Olanzapine
Ziprasidone
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 26, 2014